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FDA Clears the Quest Diagnostics Simplexa® C. difficile Molecular Test
Date:4/11/2012

M. Lieberman, M.D., medical director, infectious disease, for Quest Diagnostics and Focus Diagnostics.  "Fast, reliable PCR tests that are highly specific and sensitive in the detection of the tcdB gene, a toxin-B producing gene of C. difficile, are essential for identifying and treating this infection as well as containing its spread."

With the FDA clearance, the Simplexa C. difficile Universal Direct Test on the 3M Integrated Cycler is immediately available in the United States. Focus Diagnostics launched the test in Europe during the second quarter of 2011.

About Simplexa®

Focus Diagnostics, a wholly-owned business of Quest Diagnostics, develops and manufactures the Simplexa line of molecular test products operating on the 3M™ Integrated Cycler, a compact, portable testing platform, as part of an exclusive global collaboration with 3M™.  Simplexa was the first test kit to be FDA cleared for aiding in the detection and differentiation of the 2009 H1N1 influenza virus, in May 2010. Additional FDA-cleared Simplexa tests aid the detection of influenza A and B and respiratory syncytial virus. Several other Simplexa-branded tests, including for Clostridium difficile, Epstein Barr and BK viruses, are CE marked and distributed in Europe. In 2011, the Simplexa/3M technology won a gold Medical Design Excellence Award in the in vitro diagnostics category and an Edison Award for new science and medical diagnostic product.

To learn more about or to order Simplexa and other Focus Diagnostics tests, please contact Focus Diagnostics at 800-445-0185 (U.S.) or +49-6026-9499540 (Europe), or visit SimplexaDx.com or FocusDx.com.

About Quest Diagnostics

Quest Diagnostics is the world's leading provider of diagnostic testing, information and services that patients and doctors need to make better healthcare decisions. The company offers the broadest access to diag
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SOURCE Quest Diagnostics
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